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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
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DEPUY ORTHOPAEDICS INC US S-ROM*SLEEVE PRX ZTT, 18B-LRG; S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE Back to Search Results
Model Number 52-1485
Medical Device Problem Codes Unintended Movement (3026); Migration (4003)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 07/31/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
(b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
The patient was revised to address stem and sleeve subsided approximately 1 cm.Explanted acetabular liner, femoral head, srom sleeve and srom stem.Doi: (b)(6) 2019, dor: (b)(6) 2020, right side.
 
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
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Common Device Name
S-ROM HIP SYSTEM : HIP FEMORAL SLEEVE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10403451
Report Number1818910-2020-18094
Device Sequence Number3094256
Product Code LPH
UDI-Device Identifier10603295170648
UDI-Public10603295170648
Combination Product (Y/N)N
Initial Reporter StateFL
Initial Reporter CountryUS
PMA/510(K) Number
P070026
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2019
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date (Section B) 07/31/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model Number52-1485
Device Catalogue Number521485
Device Lot Number9054587
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 07/31/2020
Supplement Date Received by Manufacturer09/16/2020
Initial Report FDA Received Date08/13/2020
Supplement Report FDA Received Date09/21/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Concomitant Medical Products
and Therapy/Usage Dates
ALTRX +4 10D 36IDX54OD; DELTA CER HEAD 11/13 36MM +9; SROM*STM ST,36+8L NK,18X13X160; ALTRX +4 10D 36IDX54OD; DELTA CER HEAD 11/13 36MM +9; SROM*STM ST,36+8L NK,18X13X160
Outcome Attributed to Adverse Event Required Intervention;
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